FDA.reportPublic FDA data

Application 075340

Type
ANDA
Sponsor
PAR PHARM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HYDROXYUREAHYDROXYUREACAPSULE;ORAL500MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0904-6939HydroxyureaHydroxyureaMajor PharmaceuticalsANDACurrent
0904-6939HydroxyureaHydroxyureaMajor PharmaceuticalsANDACurrent
0904-6939HydroxyureaHydroxyureaMajor PharmaceuticalsANDACurrent
49884-724HydroxyureaHydroxyureaPar Pharmaceutical, Inc.ANDACurrent
49884-724HydroxyureaHydroxyureaPar Pharmaceutical, Inc.ANDACurrent
49884-724HydroxyureaHydroxyureaPar Pharmaceutical, Inc.ANDACurrent
55154-3554HydroxyureaHydroxyureaCardinal Health 107, LLCANDACurrent
55154-7143HydroxyureaHydroxyureaCardinal HealthANDACurrent
55154-7143HydroxyureaHydroxyureaCardinal HealthANDACurrent
55154-7143HydroxyureaHydroxyureaCardinal HealthANDACurrent
55154-7143HydroxyureaHydroxyureaCardinal Health 107, LLCANDACurrent
55154-7143HydroxyureaHydroxyureaCardinal HealthANDACurrent
60429-265HydroxyureaHydroxyureaGolden State Medical SupplyANDACurrent
60429-265HydroxyureaHydroxyureaGolden State Medical Supply, Inc.ANDACurrent
60429-265HydroxyureaHydroxyureaGolden State Medical Supply, Inc.ANDACurrent
60429-265HydroxyureaHydroxyureaGolden State Medical Supply, Inc.ANDACurrent
68084-284HydroxyureaHydroxyureaAmerican Health PackagingANDACurrent
68084-284HydroxyureaHydroxyureaAmerican Health PackagingANDACurrent
68084-284HydroxyureaHydroxyureaAmerican Health PackagingANDACurrent
68084-284HydroxyureaHydroxyureaAmerican Health PackagingANDACurrent
70518-0916HydroxyureaHydroxyureaREMEDYREPACK INC.ANDACurrent
70518-0916HydroxyureaHydroxyureaREMEDYREPACK INC.ANDACurrent
70518-0916HydroxyureaHydroxyureaREMEDYREPACK INC.ANDACurrent
70518-0916HydroxyureaHydroxyureaREMEDYREPACK INC.ANDACurrent
70518-0916HydroxyureaHydroxyureaREMEDYREPACK INC.ANDACurrent
70518-0916HydroxyureaHydroxyureaREMEDYREPACK INC.ANDACurrent
70518-0916HydroxyureaHydroxyureaREMEDYREPACK INC.ANDACurrent
70518-0916HydroxyureaHydroxyureaREMEDYREPACK INC.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
8624ORIG1999-02-24